Finds black particulate matter in sealed vials, dirty powder hoods and mats and a leaking boiler
The Massachusetts Department of Public Health (MDPH) has reported on its preliminary findings in its investigation of New England Compounding Center (NECC) in Framingham, Massachusetts.
Since 24 September, a widespread outbreak of fungal meningitis has affected people in 17 US states and caused 23 deaths.
The outbreak originated from a medication compounded by NECC, a facility licensed by the Massachusetts Board of Registration in Pharmacy. With the US FDA, DPH investigators have been working to identify the root causes of the infection.
While the complete scope and severity of this outbreak will not be fully understood for many weeks, public officials said, the MDPH has released its preliminary findings, which may be revised as the investigation unfolds.
When beginning the joint onsite investigation of NECC early in this outbreak, the MDPH and FDA identified ‘serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health and safety at risk’.
‘While NECC’s records show the sterility tests found no contamination, the adequacy of NECC’s sterility testing methods are currently under examination,’ the MDPH said.
Failings included final sterilisation of product not following proper standards for autoclaving pursuant to United States Pharmacopeia Standard 797 (USP 797) and NECC’s own Standard Operating Procedures. In addition, examination of NECC records indicated a systemic failure to keep products in the autoclave for the required minimum 20-minute sterilisation period necessary to ensure product sterility.
NECC also did not conduct proper validation of autoclaves pursuant to USP 797 and failed to test its autoclaves to ensure proper function.
According to the MDPH, black particulate matter was seen in several recalled sealed vials of methylprednisolone acetate. Powder hoods, intended to protect pharmacists from inhaling substances during medication preparation, within the sterile compounding area were also not thoroughly cleaned. Residual powder was observed within the hood during inspection, contamination that may subsequently lead to contamination of compounded medications.
The condition of ‘tacky’ mats, which are used to trap dirt, dust, and other potential contaminants from shoes prior to cleanroom entry, also violated the USP 797. Mats were visibly soiled with assorted debris, the MDPH said.
A leaking boiler adjacent to the requisite cleanroom created an environment susceptible to contaminant growth. A pool of water was visually observed around the boiler and adjacent walls, creating an unsanitary condition. The culture results of this potential contaminant are still pending.
The MDPH’s collaborative investigation with the FDA is comprehensive and will continue until investigators have all information needed to determine what, if any, further action should be taken against NECC and its management, the report said.
The investigation also extends to NECC’s business practices and environmental conditions surrounding the business, including the presence of a nearby recycling centre that shares ownership with NECC.
Investigators are also looking into NECC’s corporate entity, including, but not limited to, corporate ownership and governance structures at both NECC and sister companies, Ameridose and Alaunus.
MDPH will analyse and incorporate all evidence and information into a final, comprehensive report to be presented to the Board of Registration in Pharmacy, which will determine appropriate regulatory sanctions under administrative law.